Ketamine Modulation of Reward Processing fMRI in Remitted Unmedicated MDD: Double-Blind Crossover (Kotoula 2022)
Double-blind within-subject crossover neuroimaging study (Biol Psychiatry Cogn Neurosci Neuroimaging 2022 Mar; Kotoula V, Stringaris A, Mackes N, Mazibuko N et al.; PMID 34126264; DOI 10.1016/j.bpsc.2021.05.009). Participants: n=18 adults (21–65 yr) in remission from DSM-IV MDD; antidepressant-free; no current symptoms; Inventory of Depressive Symptomatology score <32 and documented prior nonresponse. Crossover: single IV ketamine (0.5 mg/kg over 40 min) and saline placebo on separate sessions ≥7 days apart; fMRI (3T, MID task, 96 trials) acquired 2 h post-infusion. Blood samples at pre-infusion, immediately post-infusion and 2 h post-infusion for ketamine, norketamine, and HNK metabolites. Primary ROIs: bilateral ventral striatum, dorsal striatum, VTA, amygdala, insula, sgACC. CT.gov: 0 hits; PubMed DataBankList: empty; no registration number in methods.
Study Arms & Interventions
Ketamine 0.5mg/kg
experimentalSingle 40-minute steady state intravenous infusion of ketamine (0.5 mg/kg)
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
40min steady state infusion
Placebo
placeboSingle 40-minute steady state intravenous infusion of 0.9% saline solution
Interventions
- Placebo nullvia IV• single dose• 1 doses total
0.9% saline solution administered via 40min steady state infusion
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Ketamine 0.5mg/kgexperimental | 37 | — | — | — | — |
| Placeboplacebo | 37 | — | — | — | — |
* The paper reports psychotomimetic effects using the PSI scale (mean 48.4 for ketamine vs 15.1 for placebo) but does not provide a summary table of clinical adverse events (TEAEs) such as counts of participants with specific medical adverse events.
* The paper reports psychotomimetic effects using the PSI scale (mean 15.1 for placebo vs 48.4 for ketamine) but does not provide a summary table of clinical adverse events (TEAEs) such as counts of participants with specific medical adverse events.